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Experimental PET Imaging Scans Before Cancer Surgery to Study the Amount of PET Tracer Accumulated in Normal and Cancer Tissues

NCT04147494

Active Not RecruitingEARLY_Phase 1

Sponsor: Jonsson Comprehensive Cancer Center

Conditions: Breast Carcinoma, Colon Carcinoma, Esophageal Carcinoma, Gastric Carcinoma, Head and Neck Carcinoma

Interventions: Computed Tomography, Gallium Ga 68 FAPi-46, Gallium Ga 68-labeled PSMA-11, Positron Emission Tomography, 18F-FDG

Countries: United States

This phase I trial studies a new imaging technique called FAPi PET/CT to determine where and to which degree the FAPI tracer (68Ga-FAPi-46) accumulate in normal and cancer tissues in patients with non-prostate cancer. The research team also want to know whether what they see on PET/CT images represents the tumor tissue being excised from the patient's body. The research team is also interested to investigate another new imaging technique called PSMA PET/CT. Participants will be invited to undergo another PET/CT scan, with the PSMA tracer (68Ga-PSMA-11). This is not required but just an option for volunteer patients. Patients who have not received an 18F-FDG PET/CT within one month of enrollment will also undergo an FDG PET/CT scan. The PET/CT scanner combines the PET and the CT scanners into a single device. This device combines the anatomic (body structure) information provided by the CT scan with the metabolic information obtained from the PET scan. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of, in the case of this research, 68Ga-PSMA-11 and 68Ga-FAPi, and 18F-FDG (if applicable). Because some cancers take up 68Ga-PSMA-11 and/or 68Ga-FAPi it can be seen with PET. CT utilizes x-rays that traverse the body from the outside. CT images provide an exact outline of organs where it occurs in patient's body. FAP stands for Fibroblast Activation Protein. FAP is produced by cells that surround tumors. The function of FAP is not well understood but imaging studies have shown that FAP can be detected with FAPI PET/CT. Imaging FAP with FAPI PET/CT may in the future provide additional information about various cancers. PSMA stands for Prostate Specific Membrane Antigen. This name is incorrect as PSMA is also found in many other cancers. The function of PSMA is not well understood but imaging studies have shown that PSMA can be detected with PET in many non-prostate cancers. Imaging FAP with PET/CT may in the future provide additional information about various cancers.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Patients with the following cancer types:

  * Breast cancer
  * Colon cancer
  * Esophageal cancer
  * Gastric cancer
  * Head and Neck cancer
  * Lung cancer
  * Ovarian cancer
  * Pancreatic cancer
  * Renal cancer
  * Uterus cancer
* Patients who are scheduled to undergo surgical resection of the primary tumor and/or metastasis
* Patient can provide written informed consent
* Patient is capable of complying with study procedures
* Patient is able to remain still for duration of imaging procedure (up to one hour)

Exclusion Criteria:

* Patient is pregnant or nursing
* Patients with any new cancer therapy between the baseline 18F-FDG PET/CT and the investigational FAPI PET/CT
* Patient has underlying disease which, based on the judgment of the investigator, might interfere with the collection of high quality data

Locations (1)

Los Angeles, California, United States